Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of oral gkt137831 in patient with type 2 diabetes and albuminuria

Conditions: Type 2 Diabetes Mellitus With Diabetic Nephropathy

Summary: nadph oxidase enzymes (nox) have been implicated in the development of several diabetic complications including diabetic nephropathy. gkt137831 is the first in class nox1/4 inhibitor. the primary objective of this study is to evaluate the efficacy of oral gkt137831 in patients with residual albuminuria despite maximal inhibition of the renin angiotensin aldosterone system.

a double-blind, placebo-controlled, randomized, multicenter, parallel group phase 2 study assessing a 12-week period of treatment with oral gkt137831 administered in addition to standard of care for patients with type 2 diabetes.

Eligibility criteria:
key inclusion criteria: * male or female aged 18 to 80 years * history of type 2 diabetes, defined as fasting plasma glucose ≥7.0 mmol/l (126 mg/dl) or a glycated hemoglobin (hba1c) \>6.5% (48 mmol/mol) on at least 2 occasions prior to screening. * albuminuria defined as a uacr of 300 to 3500 mg/g. * an egfr ≥30 ml/min/1.73 m2, as calculated by the ckd-epi formula. * must be taking an acei or an arb for at least 6 weeks prior to the first screening visit (visit 1) and during the screening period. the dose must have been stable for at least 4 weeks prior to the first screening visit (visit 1). combination therapy associating an acei and an arb is not permitted. key exclusion criteria: * history of type 1 diabetes * any other non-diabetic kidney disease(s) except for hypertensive nephropathy which is acceptable. * diagnostic or interventional procedure requiring a contrast agent within 4 weeks of the first screening visit (visit 1) or planned during the study. * history of renal transplant or planned renal transplant during the study. * a history of acute renal dialysis or acute kidney injury (defined according to the kidney disease: improving global outcomes \[kdigo\] definition) within 12 weeks of the first screening visit (visit 1) * hba1c level \>11% (97 mmol/mol). * history of hypothyroidism requiring hormone replacement therapy. * history of active cardiovascular disease * a personal or family history of long qt syndrome. * administration of any investigational product within 30 days or within 5 half-lives of the investigational agent

Keywords: type 2 diabetes proteinuria albuminuria
rapamycin versus mycophenolate mofetil in kidney-pancreas recipients

Conditions: Type 1 Diabetes

Summary: this study was designed to determine which maintenance immunosuppressive agent, rapamycin or mycophenalate mofetil, resulted in better outcome in patients with type 1 diabetes and renal failure, who presented for a kidney-pancreas transplant.

this is a randomized, prospective single center study evaluating the two maintenance drugs above.

Eligibility criteria:
inclusion criteria: * patient with type 1 diabetes and end stage renal disease. * women of childbearing potential must have had a negative pregnancy test (serum or urine). * patient agrees to participate in the study and sign an informed consent. * patient has no known contraindication to the administration of rapamycin or mycophenolate mofetil. * patient has no history of hypersensitivity to rapamycin or mycophenolate mofetil. exclusion criteria: * patient has history of a malignancy within two years, with the exception of adequately treated localized squamous or basal cell carcinoma of the skin without evidence of recurrence. * patient is currently abusing drugs or alcohol. * patient is known or suspected to have an active infection or be seropositive for hepatitis b surface antigen (hbsag), hepatitis c (hcv) or human immunodeficiency virus (hiv).

Keywords: rapamycin mycophenolate mofetil (mmf) kidney-pancreas transplant
the study of bacteriology and pathogen drug sensitivity of chronic dacryocystitis

Conditions: Dacryocystitis; Bacteriology

Summary: an observational study was designed to research the bacteriology and pathogen drug sensitivity of chronic dacryocystitis in china and optimize antibiotic therapy.

for patients diagnosed with chronic dacryocystitis，we will collect the secretions after lacrimal passage irrigation, note the characters of the secretions and send the secretions for bacteria culture, analysis and pathogen drug sensitivity.

Eligibility criteria:
inclusion criteria: 1. diagnosed with chronic dacryocystitis 2. no involvement in other drug experiment in the past 1 week exclusion criteria: 1. can not cooperate the specimen collection 2. with any other eye disease

Keywords: dacryocystitis bacteriology microbial sensitivity tests
daily everolimus in combination with trastuzumab and vinorelbine in her2/neu positive women with locally advanced or metastatic breast cancer

Conditions: HER2/Neu Over-expressing Locally Advanced Breast Cancer; Metastatic Breast Cancer

Summary: this phase iii, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in her2/neu positive women with locally advanced or metastatic breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease. locally recurrent disease must not be amenable to resection with curative intent. * her2+ status defined as ihc 3+ staining or in situ hybridization positive * patients with resistance to trastuzumab * prior taxane therapy * patients with an ecog performance status of 0 - 2 * patients with measurable disease as per recist criteria * documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. sexually active pre-menopausal women must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study; * patients must meet laboratory criteria defined in the study within 21 days prior to randomization exclusion criteria: * prior mtor inhibitors or vinca alkaloid agents for the treatment of cancer * more than three prior chemotherapy lines for advanced disease. * symptomatic cns metastases or evidence of leptomeningeal disease. previously treated asymptomatic cns metastases are allowed provided that the last treatment for cns metastases was completed \>8 weeks prior to randomization * impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of oral everolimus * peripheral neuropathy ≥ grade 2 at randomization * active cardiac disease * history of cardiac dysfunction * any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer * known hypersensitivity to any study medication * breastfeeding or pregnant

Keywords: metastatic breast cancer locally advanced breast cancer her2/neu positive breast cancer her2/neu over-expressing progressive-free survival (pfs) over survival (os) bolero bolero 3 breast cancer everolimus her+ vinorelbine herceptin trastuzumab rad001
analgesic efficacy and management of opioid-induced constipation (oic) for uncontrolled moderate - severe low back pain

Conditions: Low Back Pain

Summary: the primary objective is to assess the efficacy of oxycodone/naloxone (oxn) for the management of opioid-induced constipation (oic) compared to oxycodone controlled-release tablets (oxy) in subjects with moderate to severe low back pain and oic who require around-the-clock opioid therapy.


Eligibility criteria:
inclusion criteria include: * male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period; * the low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation; * subjects must have a self-reported history of opioid induced constipation (oic). exclusion criteria include: * subjects with rheumatoid arthritis or other inflammatory arthritis; * subjects with neuropathic conditions that have been painful or required therapy within the past 3 months; * subjects with evidence of significant structural abnormalities of the gastrointestinal (gi) tract or other significant conditions affecting gi motility; * subjects with chronic constipation not related to opioid use; * subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study; * subjects with a history of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been successfully treated. other protocol specific inclusion/exclusion criteria may apply.

Keywords: low back pain chronic pain opioid constipation moderate to severe chronic low back pain
adjuvant tislelizumab plus lenvatinib for patients at high-risk of hcc recurrence after curative resection or ablation

Conditions: Hepatocellular Carcinoma; Recurrence; Immune Checkpoint Inhibitor

Summary: though hepatic resection and ablation are the curative treatments for patients with hepatocellular carcinoma (hcc), the 5-years recurrence-free survival is lower than 30%. in recent years, several immune checkpoint inhibitors have been approved in advanced or unresectable hcc. no study about the safety and efficacy of adjuvant immune checkpoint inhibitors for patients with hcc after hepatectomy is reported.

hepatic resection and ablation are the best treatments for patients with early stage hepatocellular carcinoma (hcc) or selected intermediate or advanced disease. however, the postoperative 5-years recurrent rate is up to 70%, for whom recurrence is a major cause of death. in recent years, several immune checkpoint inhibitors have been approved in advanced hcc by official guidelines. at the same time, four randomizead controlled trials about adjvuant immune checkpoint inhibitors for postoperative hcc are ongoing. a prospective cohort study found adjuvant immune checkpoint inhibitors with or without tyrosine kinase inhibitors may improve recurrence-free survival of patients at high-risk of hcc recurrence after curative resection (doi: 10.1200/jco.2023.41.16_suppl.4119. journal of clinical oncology 41, no. 16_suppl. 4119). therefore, the investigators plan to compare the safety and efficacy of adjuvant tislelizumab plus lenvatinib to tislelizumab monotherapy for patients with high-risk factor of hcc recurrence after curative resection and ablation in a multicentric, prospective study.

Eligibility criteria:
inclusion criteria: * age from 18 to 75 years (inclusive); * diagnosis of hcc confirmed by postoperative histopathology; * underwent curative resection, as defined based on intra- and postoperative criteria; * with high-risk factors of recurrence after curative treatment, based on preoperative radiological imaging or pathology reports indicating a tumor at least 5 cm in diameter, micro- or macrovascular invasion (vp1/vp2), satellite or multinodular tumors, and/or grade 3/4 pathology; * no residual cancer detected by radiological imaging in the liver within 8 weeks after curative resection; * child-pugh 5-7 scores liver function; * eastern cooperative oncology group performance status of 0 or 1. exclusion criteria: * received neoadjuvant immune checkpoint inhibitors or tyrosine kinase inhibitors before resection or ablation; * a history of other malignancies; * history of active autoimmune or immunodeficiency diseases; * concurrent cardiac, pulmonary, cerebral, or renal dysfunction; * loss to follow-up within six months.
metabolic effects of subchronic dopamine d2 receptor blockade by antipsychotic drugs in healthy humans

Conditions: Insulin Resistance; Dyslipidemia

Summary: we hypothesized that short-term treatment with ap drugs induces insulin resistance through a mechanistic route that is independent of weight gain and that atypical drugs exert stronger effects than typical compounds in this respect. we therefore treated healthy non-obese men with olanzapine (atypical ap) or haloperidol (typical ap) for 8 days, and studied the impact of these interventions on glucose and lipid metabolism by hyperinsulinemic euglycemic clamp, isotope dilution technology and indirect calorimetry.


Eligibility criteria:
inclusion criteria: * healthy men, with and without a positive family history of schizophrenia. * 20 kg/m2 \< bmi \< 26 kg/m2 * age 20-40 years * fasting plasma glucose \< 6 mmo/l exclusion criteria: * fpg \> 6 mmol/l * bmi \> 26 kg/m2 * psychiatric disorders and/or use of antipsychotic or antidepressants drugs at present or in the past. * any significant chronic disease * renal, hepatic or endocrine disease * use of medication known to influence lipolysis and/or glucose metabolism * total cholesterol \> 7mmol/l and/or triglycerides \> 2 mmol/l * recent weight changes or attempts to loose weight (\> 3 kg weight gain or loss, within the last 3 months) * difficulties to insert an intravenous catheter * smoking (current) * severe claustrophobia (ventilated hood) * recent blood donation (within the last 2 months) * recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year * extensive sporting activities (more than 10 hours of exercise per week)

Keywords: antipsychotics olanzapine haloperidol insulin resistance dyslipidemia
pain education vs. self-management associated with movement control exercises for chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the primary aim of this study is to compare the effects of an exercise program based on movement control exercises associated with self-management advice (sme) or pain neuroscience education (pne) on the outcomes of pain intensity and pain disability in patients with chronic non-specific low back pain (clbp).

participants: one hundred and four volunteers (104) aged 18-50 years with chronic non-specific low back pain. interventions: the volunteers will be randomized into two treatment groups: self-management education and movement control exercises or pain neuroscience education and exercises based on movement control exercises. two workshops of 40 minutes each will be administered as education approach and the exercise program along 2 months ( and 12 sessions distributed over 2 months. main outcome measures: primary outcomes will include pain intensity and low back disability, and secondary outcomes will be pain catastrophizing, pain self-efficacy, kinesiophobia, exercise adherence and global perceived effect. these will be measured pre- and post-intervention and at the 1-month follow-up. statistical analysis will be conducted following treatment intent principles, and treatment effects will be calculated using a mixed linear model, considering intervention groups as a factor and assessments over time as repeated measures.

Eligibility criteria:
inclusion criteria: (1) non-specific chronic low back pain with a mechanical constituent caused by certain postures, activities, and movements, in addition to having at least 3 months of pain and/or episodes for at least half the previous 6 days, located between t12 and the gluteal folds; (2) pain intensity scores greater than 2 and greater than 14% on the oswestry low back disability index and (3) positive results in 2 or more of the 6 tests to determine movement control impairment. exclusion criteria: (1) red flags such as tumors or neoplastic diseases in the spine, inflammatory diseases, infections, and fractures; (2) central and peripheral, psychiatric, rheumatologic, and cardiac neurological diseases; (3) acute and symptomatic radiculopathy, lumbar stenosis, and spondylolisthesis; (4) pregnant women; and (5) individuals submitted to physiotherapeutic treatment during the last 6 months. finally, volunteers will be advised about the non-use of pain medications 24 hours before the evaluations.
access to kidney transplant of obese patients beginning dialysis

Conditions: Kidney Transplant Access; Obese Patients; Dialysis; Comorbidities

Summary: obesity is in constant increase all over the world and affects 35% of the global population according to the world health organisation. it is associated with other cardiovascular risk factors (particularly hypertension and diabetes) and with high morbi-mortality. it is also responsible for an increase of the risk of developing chronic kidney diseases (ckd). in fact, obese patients represent 25% of the dialysis population and picardy is one of the most affected areas. however, their access to kidney transplant is still restricted and the reasons are not completely understood.


Eligibility criteria:
inclusion criteria: * age over 18 years old. * patients with bmi≥30 kg/m2 (for study population) and 25≤bmi≤30 kg/m2(for control population) one month after dialysis initiation. * patients agree with their data collection. exclusion criteria: * patients with bariatric surgery history. * patients needed dialysis for graft dysfunction. * data loss.

Keywords: kidney transplant access obese patients dialysis comorbidities
respiratory events among premature infants

Conditions: Respiratory Syncytial Virus

Summary: assess the burden of disease associated with rsv infection with premature children in an outpatient setting.

the primary objective of this prospective study is to assess the burden of disease associated with rsv infection, as measured/determined by rates of outpatient medically attended lri, emergency room visits and hospitalization among preterm infants (32-≤36 wga) during rsv season, and its medical/health consequences, as measured by wheezing events, the infant's first rsv season, up to may 2009.

Eligibility criteria:
inclusion criteria: * written informed consent from parent/guardian to participate in study * male or female preterm infants 32-≤36 wga * infant is ≤ 6month old at the time of enrollment * parent/guardian has the ability and willingness to follow study protocol (during the first rsv season) as required by the protocol exclusion criteria: * receipt of any rsv prophylactic agent: palivizumab, igiv, or motavizumab at any time prior to enrollment * participation in trials of investigational rsv prophylaxis or rsv therapeutic agents * presence of bpd or chd (other than surgically treated pda, asd or vsd) * condition that limits life span to 6 months or less from the date of enrollment
chinese herbal fumigation with acupuncture for the knee osteoarthritis

Conditions: Osteoarthritis

Summary: to evaluate the effect of fumigation in conjunction with acupuncture for knee osteoarthritis, participators were collected from acupuncture and chinese traumatology clinic at linsen chinese medicine and kunming branch, taipei city hospital. participators were randomized into 3 groups, one for acupuncture with fumigation, one for acupuncture with diluted fumigation, one for acupuncture only.

patient population. between june 2015 and november 2017, research subjects were recruited via poster display and clinician referral, to participate in a three-armed, randomized, controlled trial to be conducted in the traumatology department linsen chinese medicine and kunming branch, taipei city hospital.

Eligibility criteria:
inclusion criteria: * osteoarthritis of knee diagnosed by x-ray films * according ahlbäck system, more than stage1 * the visual analogue scale of pain over 20mm in 100mm exclusion criteria: * the visual analogue scale of pain less than 20mm in 100mm * received injection or scope treatment over knees * received more than 3 times of operation * with severe inflammation (including fever, fluid, pus, gout, rheumatic arthritis, etc.) * with sever systemic diseases (including metastatic cancer, coronary artery disease, lung disease, etc.) * with history of skin problem after other thermal treatment * under other experiments * women with pregnant, breastfeeding or prepare for pregnancy

Keywords: osteoarthritis knee fumigation acupuncture
fetal and maternal head circumference during pregnancy in israeli population

Conditions: Maternal-Fetal Relations; Microcephaly

Summary: in this study, measurements of fetal and maternal head circumference will be collected. this data will be presented in table or graph form. the effect of maternal head circumference on fetal head circumference will be evaluated and presented in either formula or graph form.


Eligibility criteria:
inclusion criteria: * singleton pregnancy * valid first trimester sonogram exclusion criteria: * women under 18 years of age * women over 40 years of age * multi fetal pregnancy * no accurate dating of pregnancy age * participant non compliance or cannot complete contact details * technical difficulty measuring fetal or maternal skull * abnormal fetal or maternal skull * familial hereditary disease, mental retardation * chronic maternal illness * maternal on chronic medication * abnormal screening test during current pregnancy * abnormal sugar metabolism or hypertension during current pregnancy

Keywords: fetus skull ultrasonography
conquering hepatitis c via micro-elimination in southwest virginia

Conditions: Hepatitis C

Summary: the objective of this protocol is to conduct a comprehensive quantitative and qualitative assessment of the impact of our innovative collaborative telehealth hcv care model on patient treatment experiences and quality of life.

the investigators will evaluate the proportion of patients at each step of the hcv care cascade before and after implementation of the collaborative care model. additionally, participants will complete questionnaires at three time points: at the initiation of hepatitis c treatment, at treatment completion, and at the assessment of sustained virologic response. questionnaires will assess quality of life, mental health, chronic liver disease outcomes, and substance use. a subset of participants will also complete semi-structured interviews at each of the three time points. then, a smaller subset of participants will be selected for a detailed ethnographic case study focusing on treatment experiences, quality of life, forms of social support, and illness experience.

Eligibility criteria:
inclusion criteria: * 18 years or older * detectable hcv viral load * attended a clinic appointment at one of our participating sites exclusion criteria: * cognitive disability such that informed consent cannot be obtained * prisoners * unable to understand english

Keywords: hepatitis c telehealth injection drug use